November 24, 2010 by Rhiannon Smith
There are no direct provisions under REACH for nanomaterials as a separate class of substances. The Commission has confirmed that nanoparticles should simply be considered as substances, as REACH makes no reference to particle size. REACH is applicable to “a chemical element and its compounds in the natural state or obtained by any manufacturing process”.
Nanomaterials are considered as substances under REACH and therefore should be reviewed on a case-by-case basis as they may be subject to a range of REACH requirements. REACH, and its registration, risk assessment and communication obligations; downstream user duties; dossier and substance evaluation; authorisation and restriction process; as well as CLP, therefore all apply to nanomaterials.
Nanomaterials may cause a registrant to update their registration if a substance is registered in its bulk form and is subsequently introduced to the market in its nano form AND one of the conditions of REACH Article 22 are met (changes in composition, quantities, uses, and classification and labelling, or where new knowledge of the risks of a substance leads to a change in the Safety Data Sheet (SDS) or Chemical Safety Report (CSR)).
Safety data sheets
If used, Safety Data Sheets must contain “any information about the substance that is necessary to enable appropriate risk management methods to be identified and applied”. There is ongoing discussion as to whether this requires notification that a substance qualifies as a nanomaterial.
It is possible that The European Chemicals Agency (ECHA) may use a dossier evaluation to request further information on nanomaterials or recommend changes to the testing proposals submitted for that registration. ECHA can also use the compliance check in dossier evaluation to consider whether the information and risk assessment for nanoparticles is adequate and appropriate.
Should ECHA request further information or changes to the testing proposal, this may lead to questions about the applicability of the current test methods and data requirements for nanomaterials. This also leads to questions on whether EHCA will be allowed to recommend new nano-specific test guidelines, should these be brought in after the initial 2010 registration deadline. We have already advised Defra on the suitability of current ecotoxicity test guidelines in a report that you can find here.
Substance evaluation is conducted by Member States under a REACH process and can allow ECHA to request additional information, including data specifically on nanomaterials, and may lead to a restriction, an additional CSR, or a change of classification. However, this is substance-specific and cannot be applied to nanomaterials as a class of substances.
Evaluation is a long process, which can only be conducted on registered substances, and nanoparticles do not specifically meet the current criteria for prioritisation. There are also issues for nanomaterials registered under a bulk substance, as an evaluation is applicable to the whole substance rather than just the nanomaterial. In order to avoid full substance evaluation, nano-silver is undergoing a “special review” independent of bulk silver.
Authorisation and Restriction
Authorisation and restriction are substance-specific and require preparation of an Annex XV dossier. Authorisation is applicable if a nanomaterial can be demonstrated to meet the criteria for an SVHC, being either PBT/vPvB or CMR, or showing an equivalent level of concern, as identified on a case by case basis.
Nanomaterials can be subject to authorisation even if manufactured or imported at less than 1 tonne per year. If a nanomaterial is listed on the “candidate list”, then the provisions of REACH on substances in articles would also apply to articles containing nanomaterials above 0.1%. Restriction does not have a threshold tonnage and is applicable where a risk to human health or the environment is not adequately controlled and needs to be addressed.
Classification, Labelling and Packaging
CLP is required for registrations above 1 tonne but is only based on the available data. CLP does not contain specific provisions for nanomaterials, but does specify that the identification and examination of available information, the evaluation of hazard information, and the generation of new information shall be carried out on the substance in the forms or physical states in which the substance is placed on the market or in which it can be reasonably expected to be used.
The following RIP-oNs (REACH Implementation Plan on Nanomaterials) have been set up for scientific and technical support on nanomaterials: (1) substance identification; (2) specific advice on fulfilling information requirements; and (3) specific advice on exposure assessment and hazard/risk characterisation. These reports will provide information to the Commission on the applicability of current REACH regulations to nanotechnology industries, with silver, carbon nanotubes and titanium oxide as case studies.
RIP-oN 2 aims to develop specific advice on how REACH requirements on intrinsic properties of nanomaterials can be fulfilled, including the appropriateness and relevance of test methods and specific testing strategies. It will advise on the information needed for safety evaluation and risk management, in particular whether this is covered under current information requirements listed in REACH Annexes VI-X.RIP-oN 3 aims to develop advice on how to perform hazard and risk characterisation and exposure assessment for nanomaterials within the REACH context, including threshold considerations.
Is REACH compliance sufficient?
Most nanomaterials are manufactured or imported into the EU at less than 1 tonne per year and, therefore, unless they are subject to authorisation or restriction, would not be subject to REACH registration. The question of whether compliance with REACH is sufficient requires a review of several concepts and pieces of legislation.
General Product Safety Directive
The GPSD is seen as a safety net which applies only to risks not covered by more specific legislation. It only applies to consumer products. Nanomaterials, as such, are unlikely to fit within the scope of the GPSD, though mixtures and products containing or made with nanomaterials may qualify as consumer products.
Duty of Care
The Duty of Care includes the principle that industry should manufacture, import, use or place on the market substances with such responsibility and care as may be required to ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected. In principle, REACH compliance should be sufficient to ensure that nanomaterials are in compliance with EU legislation. However, compliance is not sufficient to avoid liability for any damages.
Product Liability Directive
The Product Liability Directive covers all products and includes a system of strict liability so that producers are liable for the damage caused by their defective products irrespective of any notion of fault. Product Liability Directive liability can be avoided in certain cases using the “development risk defence” (the state of the scientific and technical knowledge at the time of marketing was not such as to enable discovery of the defect). The development risk defence is applicable on a case-by-case basis across the Member States, apart from Finland and Luxembourg. However, national laws do not always agree in their interpretation of this.
The Commission holds that the development risk directive “…is not specifically directed at the practices and safety standards in use in the industrial sector in which the producer is operating, but, unreservedly, at the state of scientific and technical knowledge, including the most advanced level of such knowledge, at the time when the product in question was put into circulation”, but that “…the relevant scientific and technical knowledge must have been accessible”.
However, the definition given in the Directive leads to more questions about what constitutes objective and accessible knowledge and whether all companies, regardless of size, have the same level of obligation to monitor scientific and technical developments. Most importantly for nanomaterials, this leads to questions about the extent to which scientific uncertainties are covered under “scientific knowledge”.
Environmental Liability Directive
This piece of legislation covers the prevention and remedy of direct and indirect damage of the aquatic environment, species and natural habitats and contamination of land. The Commission is currently working on a document containing a summary of how the Environmental Liability Directive affects nanomaterials.
REACH Scope Review
By the 1st June 2012, the Commission is required to review the scope of REACH in order to avoid gaps or overlaps with other legislation. It is uncertain to what extent the Commission will use the Review to address other issues, though it is expected that particular attention will be paid to the applicability of REACH to nanomaterials and polymers and the 0.1% threshold for substances in articles.
There are no direct provisions for nanomaterials under REACH and therefore they should be reviewed on a case-by-case basis to see which REACH regulations are applicable. Most nanomaterials are manufactured or imported into the EU at less than 1 tonne per year and, unless subject to authorisation or restriction, would not be subject to REACH registration. REACH Implementation Plans on Nanomaterials, covering identification, information requirements and exposure assessment and hazard/risk characterisation, will provide advice to the Commission on the applicability of REACH to nanomaterials. However, the question of whether compliance with REACH is sufficient requires a review of several concepts and pieces of legislation.